Outcomes of Autologous Bone Marrow-derived Mononuclear Cell Transplantation in the Management of Neurological Sequelae

Phase 1

Completed

• Conditions: Sequelae of Injuries of Head
• Interventions: Biological: autologous bone marrow-derived mononuclear cell transplantation; Other: Rehabilitation therapy

• Registration Number: NCT05293873
• Lead Sponsor: Vinmec Research Institute of Stem Cell and Gene Technology

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of autologous bone marrow-derived mononuclear cell transplantation in the management of neurological sequelae after traumatic brain injury

Detailed Description

To evaluate the safety and efficacy of autologous bone marrow-derived mononuclear cell transplantation in 25 patients with neurological sequelae after traumatic brain injury compared with 25 patients in control group (no intervention) at the time points of baseline, 3rd month (D90), 6th month (D180), and 12th month (D360).

Study Timeline

• Study First Submitted: 2019-03-27
• Study Start: 2021-04-01
• Study First Submitted QC: 2022-03-14
• Study First Posted: 2022-03-24
• Primary Completion: 2023-03-30
• Study Completion: 2023-06-30
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age: from 20 to 50 years
• Gender: either sex
• Duration after Brain trauma: 6 - 12 months
• Functional Independence Measure - FIM < 69
• Closed head injury

Exclusion Criteria

• Neurologic impairment or neurological disease before the time of the accident.
• Active infections
• Tumours or failure of heart, lung, liver or kidney, respiratory distress syndrome
• Anaemia, clotting disorder
• Cancer
• Pregnancy
• Alcoholic
• Patient was unemployed or did not attend school before the accident.
• Severe injuries: spinal cord injury, pelvic inflammation, cardiopulmonary

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment (BM-MNC trasnplatation)	autologous bone marrow-derived mononuclear cell transplantation	Autologous bone marrow-derived mononuclear cell will transplant at baseline, and the second transplantation will be performed 6 months after the first transplantation and combination with rehabilitation therapy
Treatment (BM-MNC trasnplatation)	Rehabilitation therapy	Autologous bone marrow-derived mononuclear cell will transplant at baseline, and the second transplantation will be performed 6 months after the first transplantation and combination with rehabilitation therapy
Control group	Rehabilitation therapy	rehabilitation therapy

Primary Outcome Measures

Name	Time	Method
Adverse events and serious adverse events	up to the 12-month period following treatment	Incidence of the adverse events or serious adverse events after transplantation
Functional Independence Measure	up to the 12-month period following treatment	Functional Independence Measure assess and grade the functional status of patient
Extended Glasgow Outcome Scale	up to the 12-month period following treatment	Extended Glasgow Outcome Scale classifies global outcome in TBI survivors

Secondary Outcome Measures

Name	Time	Method
to monitor the functional metabolic changes in the brain of the patients	up to the 12 months after transplantation	The PET-CT scan will be repeated to monitor the functional metabolic changes in the brain of the patients
Short Form 36	up to the 12-month period following treatment	Short Form 36 items will be performed to evaluate the overall health of the patients for their quality of life

Trial Locations

Locations (1)

Vinmec Research Institute of Stem Cell and Gene Technology; 🇻🇳 Hanoi, Vietnam